Metronomic chemotherapy for hormone refractory prostate cancer (HRPC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15649-15649
Author(s):  
S. Hoshi ◽  
K. Numahata ◽  
K. Hoshi ◽  
K. Suzuki ◽  
K. Ono ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Bone Scan ◽  
Performance Status ◽  
Metronomic Chemotherapy ◽  
Response Duration ◽  
Complete Regression ◽  
Hormone Refractory Prostate Cancer ◽  
Median Response ◽  
Hormone Refractory

15649 Background: Low dose continuous chemotherapy (metronomic chemotherapy) is trying to many advanced cancers. Metronomic chemotherapy has important anti-angiogenic activity to tumor vessels. For patients who progressed after docetaxel, no standard options exist. We have experienced complete regression of bone metastases on super scan by low does cisplatin, UFT, diethylstilbestrol, and dexamethasone (CUDD) in a patient with HRPC (Int JCO, 8,118, 2003). Methods: CUDD consisting of weekly 5 mg/body of cisplatin plus 125 mg/body of diethylstilbestrol and daily 300–450 mg of UFT/day plus 0.5–1 mg of dexamethasone were given to 47 HRPC patients, (median and range of age: 66 and 52–72, respectively). The ECOG performance status was 0 to 1. Gleason score was 7 in 10 patients and 8 in 17 patients and 9 in 20 patients, respectively. Metastatic site was bone in 45 (EOD grade 1:10, 2:18, 3: 15, 4:2), lymph node in 8. Six cases became refractory to docetaxel were treated with CUDD plus CPM (50 mg/day). Results: Among the 45 patients assessable for bone metastasis, 12 (27 %) obtained marked improvement on bone scan. One was EOD grade 4 (super bone scan) and 9 were EOD grade 1–3. Eighteen (40 %) were stable and 15 (33%) progressed on bone scan. Among 8 patients of lymph node metastasis, 3 (38%) showed partial response, 2 (25%) no change and 3 (38%) progression. Twenty-five (53 %) out of 47 patients showed a PSA decline of 50% or greater. Among the 25 patients assessable for bone pain, 7 (28%) improved, 12 (48%) remained stable and 6 (24%) progressed. Their median response duration and median survival time were 8 months (range; 2 to 44 months) and 20 months (range, 4 to 48 months), respectively. Their median response duration was 3 months. Three of 6 refractory to docetaxel were responded to CUDD plus CPM. Their median response duration was 10 months. Conclusions: CUDD is effective in almost half of hormone refractory prostate cancer patients and has advantage of minimal side effect. Three of 6 docetaxel refractory cases also responded to CUDD plus CPM. No significant financial relationships to disclose.

Phase II study of intravenous vinorelbine plus hormone therapy in hormone-refractory prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14601-14601
Author(s):  
E. Silva ◽  
F. Silva
Keyword(s):  
Prostate Cancer ◽  
Elderly Patients ◽  
Prostate Specific Antigen ◽  
Phase Ii ◽  
Performance Status ◽  
Specific Antigen ◽  
Hormone Refractory Prostate Cancer ◽  
Phase Ii Studies ◽  
Hormone Refractory ◽  
Grade 3

14601 Background: Vinorelbine (VRL) has been shown to be active in hormone-refractory prostate cancer (HRPC) in Phase II studies, alone or in combination. Its moderate toxicity profile is well tolerated in elderly patients. The purpose of this study was the investigation of the efficacy of vinorelbine and its toxicity. Methods: Patients with metastatic prostate cancer, progressive after hormonal therapy, receive intravenous VRL 30 mg/m2 on days 1 and 8 every 3 weeks, and hydrocortisone 40 mg/day. Previous chemotherapy was allowed if stopped 6 months before. 44 received VRL according to the protocol. Inclusion criteria: hormone refractory prostate cancer patients PSA >20; performance status WHO < 2. The primary endpoint was prostate specific antigen (PSA) levels, pain, and WHO performance status. Their mean (range) age was 71 (45–80) years, their median prostate specific antigen (PSA) level was 286 (38–950) ng/ml, and the median Gleason score was 8 (7 to 9). 38 patients had had previous chemotherapy. Results: Among the 44 patients, 7 with less than 3 cycles were not evaluated. Patients received a mean (range) of 9 (3–44) cycles of therapy. 6 patients (14%) had not been dispensed prior chemotherapy and 38 (86%) had; 19 (43%) had 2 lines of chemotherapy and 19 (43%) had 1 line. The median follow-up was 13 months. There were no reported drug related Grade 3 toxicities. Only 2 patients required a blood transfusion. Tumour responses: 7 (16%); 17 (39%) PSA stable; 13 (29%) PSA progression, 7 not evaluated. Time of PSA response was 7 months; time to progression: 7 months. Conclusions: Vinorelbine (VRL) is a safe regimen in previous poly-chemotherapy treated hormone-refractory prostate cancer elderly patients and even with response and efficacy. No significant financial relationships to disclose.

MER-101–03, a multicenter, phase II study to compare MER-101 20mg tablets to intravenous zoledronic acid 4mg in prostate cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5161-5161
Author(s):  
C. McHugh ◽  
K. Madigan ◽  
A. Walsh ◽  
J. Fox ◽  
T. W. Leonard ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Phase Ii ◽  
Performance Status ◽  
Hormone Refractory Prostate Cancer ◽  
Open Label ◽  
Secondary Endpoints ◽  
Hormone Refractory

5161 Background: The primary objective of this study is to examine the pharmacodynamic effects of two different regimens of zoledronic acid, Orazol 20 mg tablets versus Zometa 4mg IV infusion once-monthly therapy on biomarkers in male bisphosphonate-naïve hormone-refractory prostate cancer patients. Methods: The study is an open-label, multi-center phase II clinical trial to compare oral Orazol 20 mg tablets weekly, to infusions of intravenous Zometa 4mg monthly, in males with hormone-refractory prostate cancer, bone metastases, and no prior bisphosphonate treatment. Patients were assigned into one of three cohorts. The three treatments administered were IV Zometa, 4 mg, 15 minute infusion, Day 0 and Day 28; Orazol po, 20 mg, Days 0, 7, 14, 21, 28, 35, 42, and 49; and Orazol po, 20 mg, Days 0, 1, 2, 3, 28, 35, 42, and 49. The study population consisted of men with hormone refractory prostate cancer as evidenced by history of rising PSA levels (last 2 of 3 PSA levels must be above nadir), who are bisphosphonate-naive, and have radiographically-confirmed bone metastases. Efficacy assessments: The primary endpoints are the assessment of response of four biomarkers, urinary NTX, serum CTX, serum bone specific alkaline phosphatase, and serum calcium on days -7, 0, 7, 14, 21, 28, 35, 42, 49, and 56. Secondary endpoints are assessments of performance and pain scores based on ECOG performance status, BPI, and analgesic use. Safety assessments include physical examinations, vital signs and body weight, hematology panel, urinalysis, and blood chemistry panel. Results: The results demonstrated a rapid decrease for all four biomarkers. This decrease was seen at seven days, and was sustained throughout the study. There were no statistically significant differences between any of the treatments in the primary and secondary endpoints. Conclusions: From the results of MER-101–03, Orazol weekly therapy appears to be as effective as Zometa, based on the biomarkers analyzed. Orazol offers a substantial improvement in therapy over IV infusion for patients, with efficacy that is at least comparable based on the results obtained here. No significant financial relationships to disclose.

Multiple Tumor Marker Elevation in Androgen Ablation-Refractory Prostate Cancer with Long-Term Response to Metronomic Chemotherapy: A Case Report

2010 ◽  
Vol 25 (4) ◽  
pp. 243-247 ◽  
Author(s):  
Mariangela Massaccesi ◽  
Franca Forni ◽  
Pasquale Spagnuolo ◽  
Gabriella Macchia ◽  
Samantha Mignogna ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Colon Adenocarcinoma ◽  
Metronomic Chemotherapy ◽  
Serum Levels ◽  
Hormone Refractory Prostate Cancer ◽  
Multiple Tumor ◽  
Androgen Ablation ◽  
Antiangiogenic Therapies ◽  
Specific Tumor ◽  
Hormone Refractory

Outcomes in hormone-refractory prostate cancer are very poor. The time from progression to death is only 12–19 months. We present the case of a 69-year-old man with hormone-refractory prostate cancer and bone metastases treated with metronomic chemotherapy (cyclophosphamide based). He had had a colon adenocarcinoma ten years before. The atypical features of this case were an unusually long-lasting response to metronomic chemotherapy and an increase in serum levels of some non-prostate-specific tumor markers (CEA and CA 19–9) that was not related to a relapse of colon cancer. We hypothesize a potential role of hypoxia inducing CA 19–9 and CEA expression in tumor cells, which may predict the development of progressive resistance to antiangiogenic therapies.

scholarly journals 1603: PTEN - AKT- P27 KIP1 Expression Profile in Benign, Cancerous, Lymph Node Positive and Hormone Refractory Prostate Cancer Tissue

2005 ◽  
Vol 173 (4S) ◽  
pp. 434-434
Author(s):  
Axel S. Merseburger ◽  
Joerg Hennenlotter ◽  
Marcus Horstmann ◽  
Ruth Knuechel-Clarke ◽  
Carolin Mueller ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Lymph Node ◽  
Expression Profile ◽  
Cancer Tissue ◽  
Hormone Refractory Prostate Cancer ◽  
Node Positive ◽  
Prostate Cancer Tissue ◽  
Lymph Node Positive ◽  
Hormone Refractory ◽  
P27 Kip1

Polyamine-reduced diet in metastatic hormone-refractory prostate cancer (HRPC) patients

2003 ◽  
Vol 31 (2) ◽  
pp. 384-387 ◽  
Author(s):  
B. Cipolla ◽  
F. Guillé ◽  
J.-P. Moulinoux
Keyword(s):  
Prostate Cancer ◽  
Performance Status ◽  
Specific Antigen ◽  
World Health Organisation ◽  
World Health ◽  
Hormone Refractory Prostate Cancer ◽  
Cancer Specific Survival ◽  
Pain Status ◽  
Intestinal Decontamination ◽  
Hormone Refractory

Polyamine (PA) deprivation is effective in prostate carcinoma models. We have assessed the observance by patients, tolerance and side effects of a PA-reduced diet (PRD) and intestinal decontamination (ID), in order to reduce PA dietary and intestinal bacterial pools, in metastatic, hormone-refractory prostate cancer (HRPC) patients. A total of 13 volunteers (mean age, 67±10 years) with metastatic HRPC were proposed for PRD and ID (0.75 g/day of oral neomycin every other week). The mean time from HRPC diagnosis to the start of the diet was 12±8 months. Of the total 13, seven patients had received prior chemotherapy or Estramustine phosphate. PRD was obtained after HPLC assessment of PA contents in current foods and given 5 days a week. Toxicity, performance and pain status were assessed according to the World Health Organisation and EORTC scales. Prostatic specific antigen (PSA), blood counts, ionograms, transaminases and erythrocyte PA spermidine (Spd) and spermine (Spm; assessed by HPLC) were evaluated regularly. Mean observance was 8±7 months (range, 2–26 months). One case of grade II toxicity to neomycin was observed. Cancer-specific survival (after the diet) was 14±7 months, and two patients are still alive. All the other patients have died of their cancer at 12±6 months (range, 4–20 months). Cancer-specific survival after hormonal escape was 27±11 months (range, 9–45 months). Performance status was improved during the regimen and deteriorated 3 months after stopping. Pain score was improved (1.3 versus 0.6; P=0.04) during the diet and increased (2.1 versus 0.3) 3 months after stopping. Erythrocyte Spd (11.6±7 versus 7.7±2 nmol/8×109 erythrocytes; P=0.036) and Spm (7±6 versus 3.9±1.6 nmol/8×109 erythrocytes; P=0.036) levels were significantly reduced at 3 months. One patient had a >50% reduction in PSA, three patients had PSA stabilization for 6 months. PSA progression was observed in all other patients. No significant modification of other studied biological parameters was noted. Reducing PA dietary intake and ID is a well-observed and tolerated regimen and seems to be beneficial for patient quality of life and pain control. Patients with low initial PSA can experience durable stabilization. These encouraging results in such an aggressive disease certainly warrant further investigation.

Ixabepilone (Epothilone B Analogue BMS-247550) Is Active in Chemotherapy-Naive Patients With Hormone-Refractory Prostate Cancer: A Southwest Oncology Group Trial S0111

2005 ◽  
Vol 23 (34) ◽  
pp. 8724-8729 ◽  
Author(s):  
Maha Hussain ◽  
Catherine M. Tangen ◽  
Primo N. Lara ◽  
Ulka N. Vaishampayan ◽  
Daniel P. Petrylak ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Performance Status ◽  
Specific Antigen ◽  
Progression Free Survival ◽  
Hematologic Toxicity ◽  
Hormone Refractory Prostate Cancer ◽  
Grade 5 ◽  
Psa Response ◽  
Hormone Refractory ◽  
Grade 3

Purpose The epothilones are a new class of tubulin-polymerizing agents with activity in taxane-sensitive and resistant tumor models. We evaluated ixabepilone (BMS-247550) in patients with metastatic hormone-refractory prostate cancer (HRPC). Methods Eligible patients had chemotherapy-naive metastatic HRPC, a Zubrod performance status of 0 to 2, and adequate organ function. All patients received BMS-247550 at 40 mg/m2 over 3 hours every 3 weeks. The primary end point was proportion of patients achieving a prostate-specific antigen (PSA) response. Results Forty-eight patients with metastatic HRPC were registered. Forty-two patients were eligible, with a median age of 73 years and a median PSA level of 111 ng/mL; 78% had bone-only or bone and soft tissue metastases, and 88% had objective radiologic disease progression at registration. Grade 3 and 4 adverse events (AEs) occurred in 16 and three patients, respectively. All grade 4 toxicities were neutropenia or leukopenia. The most frequent grade 3 AEs were neuropathy (eight patients), hematologic toxicity (seven patients), flu-like symptoms, and infection (five patients each). There were no grade 3/4 thrombocytopenia or grade 5 AEs. There were 14 confirmed PSA responses (33%; 95% CI, 20% to 50%); 72% of PSA responders had declines greater than 80%, and two patients achieved an undetectable PSA. The estimated median progression-free survival is 6 months (95% CI, 4 to 8 months), and the median survival is 18 months (95% CI, 13 to 24 months). Conclusion Ixabepilone has demonstrated activity in patients with chemotherapy-naive metastatic HRPC. Major toxicities were neutropenia and neuropathy. Further testing to define its activity relative to standard therapy is warranted.

scholarly journals Efficacy and toxicity of mitoxantrone and oral etoposide in the treatment of hormone-refractory prostate cancer: pilot study

2010 ◽  
Vol 8 (3) ◽  
pp. 336-338
Author(s):  
Rafael Kaliks ◽  
Camila Guerra ◽  
Auro Del Giglio
Keyword(s):  
Prostate Cancer ◽  
Pilot Study ◽  
Partial Response ◽  
Stable Disease ◽  
Response Rate ◽  
Response Duration ◽  
Oral Etoposide ◽  
Hormone Refractory Prostate Cancer ◽  
Toxicity Response ◽  
Hormone Refractory

ABSTRACT Objective: To evaluate the efficacy and toxicity of the association of mitoxantrone and oral etoposide. Methods: Twelve consecutive patients with metastatic hormone-refractory prostate cancer were treated with mitoxantrone and oral etoposide. Toxicity, response rate and response duration were assessed. Results: Partial response was observed in two patients (response duration of seven and four months) and one patient had stable disease (during four months). Mitoxantrone and oral Etoposide were well tolerated and did not affect tolerability to subsequent chemotherapy. Conclusion: Mitoxantrone and oral etoposide association is an active and well-tolerated regimen in hormone-refractory prostate cancer.

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